Haemophilus b polysaccharide vaccine (Intramuscular, Injection)

Haemophilus b polysaccharide vaccine is a vaccine that helps protect against infections caused by Haemophilus influenzae type b (Hib) bacteria. It works by prompting your body to make its own antibodies to fight the disease.

The following information is specifically about the Haemophilus b polysaccharide vaccine.

Infection from Haemophilus influenzae type b (Hib) bacteria can lead to severe illnesses, such as meningitis, which affects the brain; epiglottitis, which can result in death from suffocation; pericarditis, which affects the heart; pneumonia, which impacts the lungs; and septic arthritis, which affects the bones and joints. Hib meningitis can cause death in 5 to 10% of infected children. Additionally, around 30% of children who survive Hib meningitis may experience serious long-term problems, such as cognitive impairment, hearing loss, seizures, or partial blindness.

Immunization against Hib is advised for all children aged 24 months up to 5 years (i.e., until their 5th birthday). Moreover, immunization is recommended for children aged 18 to 24 months, particularly:

• Children in day-care settings.
• Children with chronic health issues that increase their risk of Hib disease. These issues include lack of spleen, sickle cell disease, immune deficiency syndromes, weakened immune systems, and Hodgkin's disease.
• Children aged 18 to 24 months who have previously had Hib disease. These children can get sick again if they are not vaccinated. Children who had Hib disease at 24 months of age or older do not need to be vaccinated, as most children in this age group will develop their own antibodies.
• Children with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• Children from certain racial backgrounds, such as American Indian and Alaskan Eskimo. These children appear to have a higher risk of Hib disease.
• Children who live in close quarters with others. Living closely with others raises a child's risk of coming into contact with those who have Hib infection or carry the bacteria.

It is recommended that children vaccinated at 18 to 24 months receive a second dose of the vaccine, as they might not produce enough antibodies for full protection against Hib disease. Children who were first vaccinated at 24 months of age or older do not need a second dose.

This vaccine is available only through your doctor or another licensed healthcare provider.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it provides. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

This vaccine is not recommended for children under 18 months of age.

Breast Feeding

Studies indicate that this medication presents minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there may be an interaction. In these situations, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below when you receive this vaccine. The following interactions are highlighted based on their potential significance but are not a complete list.

It is generally not recommended to receive this vaccine with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the medicines.

• Cyclosporine
• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical issues may impact the use of this vaccine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Fever or
• Serious illness—The symptoms of your condition might be mistaken for possible side effects of the vaccine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Symptoms of allergic reaction

• Difficulty in breathing or swallowing
• hives
• itching (especially of feet or hands)
• reddening of skin (especially around ears)
• swelling of eyes, face, or inside of nose
• unusual tiredness or weakness (sudden and severe)

Check with your doctor immediately if any of the following side effects occur:

Rare

• Convulsions (seizures)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• fever up to 102 °F (39 °C) (usually lasts less than 48 hours)
• irritability
• lack of appetite
• lack of interest
• redness at place of injection
• reduced physical activity
• tenderness at place of injection

Less common

• Fever over 102 °F (39 °C) (usually lasts less than 48 hours)
• hard lump at place of injection
• itching
• joint aches or pains
• skin rash
• swelling at place of injection
• trouble in sleeping
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form: For prevention of Haemophilus influenzae type b infection: Adults and children 5 years of age and older—Use is not recommended. Children up to 18 months of age—Use is not recommended. Children 18 to 24 months of age—Use and dose must be determined by your doctor. Children 24 months to 5 years of age—One dose injected under the skin or into a muscle.